a three-part study to evaluate the safety, pharmacokinetics and pharmacodynamics of mk-2640 in healthy participants (part i) and participants with type 1 diabetes mellitus (parts ii and iii) (mk-2640-001)

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of part i of this study is to evaluate the safety and tolerability of intravenous (iv) doses of mk-2640 in healthy participants and to obtain preliminary plasma pharmacokinetic profiles of mk-2640. the purpose of parts ii and iii of this study is to evaluate the safety and tolerability of iv doses of mk-2640 and regular human insulin (rhi), and to evaluate the pharmacokinetic and pharmacodynamic profile of mk-2640 and rhi in participants with type 1 diabetes mellitus (t1dm). part ii will be initiated only if part i general safety, tolerability and other observed data are supportive of progression to part ii. part iii will be initiated only if parts i and ii general safety, tolerability and other observed data are supportive of progression to part iii.


Eligibility criteria:
inclusion criteria (part i): * healthy male or healthy female of non-child bearing potential * in good health * is a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months inclusion criteria (parts ii and iii): * male or female of non-child bearing potential * has t1dm for at least 12 months * on stable doses of insulin * in good health * is a nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months exclusion criteria: * is mentally or legally incapacitated, or has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years * has a history of clinically significant endocrine (except t1dm for part ii subjects), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases * is positive for hepatitis b surface antigen, hepatitis c antibodies or human immunodeficiency virus (hiv) * has a history of cancer (malignancy), except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix * has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, had major surgery, donated or lost 1 unit of blood within 4 weeks prior to the screening visit * has participated in another investigational trial within 4 weeks prior to the screening visit * is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of trial drug, throughout the trial, until the posttrial visit * consumes greater than 3 glasses of alcoholic beverages daily * consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day. * is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months exclusion criteria (parts ii and iii): * has a history of diabetic ketoacidosis in the last 6 months. * has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 2 weeks prior to dosing * has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation * has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in regular human insulin, or to any e. coli-derived drug product